NCT00777907已完成3 期
Complete Occlusion of Coilable Aneurysms
Chestnut Medical Technologies4 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2008年10月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 4
- 主要终点
- Effectiveness: Proportion of subjects whose target aneurysm shows complete occlusion on angiogram with <=50% stenosis of the parent artery. Safety: Proportion of subjects with ipsilateral major stroke or neurologic death.
研究概览
简要总结
To compare the safety and effectiveness of Pipeline Embolization Device to coil embolization for the treatment of coilable wide-necked intracranial aneurysms
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 to 75 years, inclusive
- •Patient has a single target IA that:
- •is located in the following regions of the internal carotid artery: i. Paraophthalmic (including paraclinoid, ophthalmic and hypophyseal segments) ii. Cavernous iii. Petrous
- •is saccular
- •has a parent vessel with diameter 2.5-5.0 mm
- •If target IA has a neck >4 mm, at least 2 of 3 members of an independent expert committee (IEC) have confirmed that coil embolization with optional adjunctive techniques** has a very high likelihood of procedural success (i.e., coil placement and retention)
- •Subject has provided written informed consent using the IRB-approved consent form
- •Subject has the necessary mental capacity to participate and is willing and able to comply with protocol requirements
- •** Adjunctive techniques include intravascular balloons ["balloon remodeling"], 3D coils, dual catheter techniques.
排除标准
- •Target IA has BOTH neck >4 mm AND size (maximum fundus diameter) >10 mm
- •More than one IA requires treatment in the next 6 months
- •Subarachnoid hemorrhage in the past 60 days
- •Any intracranial hemorrhage in the last 42 days
- •Major surgery in the last 42 days
- •Coils in place in the target IA
- •Unstable neurologic deficit (i.e., any worsening of clinical condition in the last 30 days)
- •Known irreversible bleeding disorder
- •Platelet count < 100 x 103 cells/mm3 or known platelet dysfunction
- •Inability to tolerate, documented evidence of adverse reaction or contraindication to study medications
- •Prior stent placement at target site
- •Contraindication to CT scan AND MRI
- •Known allergy to contrast used in angiography that cannot be medically controlled
- •Known severe allergy to platinum or cobalt/chromium alloys
- •Relative contraindication to angiography (e.g., serum creatinine > 2.5 mg/dL)
- •Woman of child-bearing potential who cannot provide a negative pregnancy test
- •Evidence of active infection at the time of treatment
- •Other known conditions of the heart, blood, brain or intracranial vessels that carry a high risk of neurologic events (e.g., severe heart failure, atrial fibrillation, known carotid stenosis)
- •Current use of cocaine or other illicit substance
- •Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments to 180 days
- •Extracranial stenosis greater than 50% in the carotid artery
- •Intracranial stenosis greater than 50% in the treated vessel
结局指标
主要结局
Effectiveness: Proportion of subjects whose target aneurysm shows complete occlusion on angiogram with <=50% stenosis of the parent artery. Safety: Proportion of subjects with ipsilateral major stroke or neurologic death.
时间窗: 180 days
次要结局
- Incidence of ipsilateral major stroke(180 days)
- Change from baseline in neurologic signs or symptoms related to the target aneurysm(180 days)
- Change in modified Rankin scale (MRS)(180 days, 1, 3 and 5 years)
- Incidence of device-related adverse events(180 days, 1, 3 and 5 years)
- Rate of complete target aneurysm occlusion(1, 3 and 5 years)
研究者
研究点 (4)
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